Obesity is the leading cause of the worldwide type 2 diabetes epidemic and many other obesity related disorders. Over eighty percent of type 2 diabetes is attributed to excess weight. Currently, over two-thirds of adults in the United States are overweight or obese, as are about one-and-a-half billion people worldwide. Failure to control obesity underlies the increasing cost of diabetes care which, in the U.S., rose to $245 billion in 2012.
Current standard medical care for obesity and type 2 diabetes and related disorders involves advice to adopt a healthy lifestyle and the prescription of oral and injected medication. These approaches, however, have poor long-term efficacy. The most effective therapy for both obesity and related disorders, including type 2 diabetes, is widely considered to be surgical intervention, such as bariatric surgery, Roux-en-Y gastric bypass and the related sleeve gastrectomy and biliopancreatic diversion. These surgical procedures, particularly gastric bypass surgery, are highly effective at promoting weight loss and controlling type 2 diabetes, with reported drug-free remission of diabetes in 40-90% of patients. However, bariatric surgery is not available to the vast majority of those who could benefit from it worldwide, due to its high cost and medical guidelines which limit its use. In addition, many medically eligible people decline surgery due to concerns about short and long-term risks.
The unmet clinical need is a safe, broadly applicable, low-cost alternative to bariatric surgery for the management of obesity, and related disorders and co-morbidities, including type 2 diabetes mellitus.
While research studies have demonstrated that delivering nutrients directly to the small intestine and bypassing the stomach can increase satiety and reduce subsequent food intake, there is still an unmet need for a safe, effective, broadly applicable, low-cost therapy for achieving direct nutrient delivery to the upper intestine that simulates the benefit of gastric bypass.